NCT02103179

Brief Summary

The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 3, 2014

Status Verified

March 1, 2014

Enrollment Period

7.8 years

First QC Date

March 31, 2014

Last Update Submit

March 31, 2014

Conditions

Keywords

Extrahepatic cholangiocarcinomaECCVEGF signaling

Outcome Measures

Primary Outcomes (1)

  • the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis.

    the sections would be collected as previously described.Western blot,immunohistochemistry,PCR would be conducted to find out the variation between the normal liver tissue and tumor,tumor and meta(if have).

    the day when conducting surgery (day 1)

Study Arms (1)

ECC patients

Extrahepatic cholangiocarcinoma patients treated by surgical treatment

Procedure: surgical treatment

Interventions

all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.

ECC patients

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Extrahepatic cholangiocarcinoma patients underwent surgical therapy

You may qualify if:

  • Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
  • Child-Pugh A or B
  • well preserved renal and hematopoietic Function
  • receive surgical therapy
  • achieve complete section accessed by contrast-enhanced CT

You may not qualify if:

  • incomplete section
  • remote metastasis
  • Child-Pugh C
  • combination with other hepatobiliary disease
  • suffer from other tumors concurrently or in last five years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cut tissue into small pieces (\~2 mm2)and wash in drops of saline (1x PBS). Place pieces individually into LN2 in Styrofoam cup. Transfer pieces into LN2-cooled 1.5 mL cryovial. Pour out excess LN2 from vial, then seal and keep in LN2 until freezer storage.

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Ming Kuang, MD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

July 1, 2006

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

April 3, 2014

Record last verified: 2014-03

Locations